FDA Grants GSK’s Jemperli Accelerated Approval for Stage II/III Rectal Cancer
On October 19, 2026, the U.S. Food and Drug Administration granted accelerated approval to GSK’s Jemperli (dostarlimab-gxly), used alone, for previously untreated adults with stage II or III locally advanced rectal cancer whose tumors are dMMR or MSI-H, as confirmed by an FDA-authorized test. The approval expands Jemperli’s U.S. authorized use to this biomarker-defined rectal-cancer population.
The supplied wire explicitly reports that the FDA approved GSK’s Jemperli, and the supporting context specifies that this was accelerated approval for previously untreated adults with stage II or III locally advanced rectal cancer whose tumors are dMMR or MSI-H. This is a material, forward-looking regulatory authorization that expands Jemperli’s U.S. treatment population and directly affects GSK’s commercial outlook. The approval occurred on October 19, 2026, but no exact FDA decision time is provided; 16:26:42Z is therefore retained as an estimate based on the first wire report, with lower timestamp confidence. The prior match to event 2452 is appropriate because this approval is the next milestone in the existing Jemperli rectal-cancer FDA review storyline. GSK is the only approved stakeholder because the evidence establishes a direct impact on its product and revenue opportunity; potential effects on competitors and diagnostic companies are indirect or speculative.
GSK'S JEMPERLI RECEIVES FDA APPROVED FOR STAGE II – STAGE III RECTAL CANCER